Reprinted Articles

One of the controversial issues with interpretation of ISO 9001:2000 Standard and others is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 9001:2000, element 4.2.3, “Documents required by the quality management system shall be controlled.” Let’s see if a form qualifies to be a “document” that shall be controlled.

Forms and tables are frequently used as lower-level documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instructions if a simple table is sufficient to provide these instructions. One of the typical non-conformities that companies get during audits of their quality management systems is against forms that are not part of the documentation system.

When questioning the validity of a form without a number, I often hear: ?This is just a form.? It always escapes me, why should a form be different from any other instruction? How would we know that we need a form if it is not referenced in our documentation system? After all, if you are not managing forms by assigning document or part number and decide to modify them, how can you be sure that the latest revision is being revised? At best it would be difficult. In practice it would be impossible. Well, exactly what is a form? A quick quiz will help answer this question. If we have a list of directions telling us to:

- draw a two-column table

- enter your company name into the first column

- enter your company?s URL into the second column

I would bet that most of us would call this three-line direction an instruction. So this instruction, since it is a ?real? instruction, shall be controlled.

Now, let?s imagine that we were given a two-column form, only being asked to complete it. where the first column is titled ?You company name? and the second column ?Company?s URL?. Obviously, we would enter our company name and our Website address in the table. It means that we interpreted the table as an ?instruction?.

If we concur that the first three-line instruction in written in English was a “real” instruction, that needs to be controlled, the other, completed form, resulting in the same output, must also be an instruction! Shouldn’t this type of an instruction be controlled also?

It appears that the puzzlement about forms and their control comes from the fact that forms serve two purposes. Blank forms are instructions in tabular language. After a form is filled out, it becomes a record. Records, as a rule, do not have a part or document number or a revision level. Records are controlled by different processes. Remember this and treat your forms as instructions controlled by your documentation procedure. There are a couple of tests you may take when you are thinking about not controlling your form.

- If you created a form and found it had been changed, would you like to know who did it and why?

- If you changed your form, would you like personnel to use the most resent revision?

- If you were on vacation, would you like folks to be able to find your form just by finding a reference to it?

If you answered, “yes” at least once, your form should be controlled per your documentation management procedure.

Tags: Business